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Regulatory Affairs Officer at Demo S.A.

Athens, Attica, Greece -

Full Time

Start Date

Immediate

Expiry Date

12 May, 26

Salary

0.0

Posted On

11 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Regulatory Documentation, DCP Applications, MRP Applications, National Applications, Regulatory Authorities Liaison, Policy Evaluation, Dossier Compilation, Product Registration, Regulatory Compliance, Scientific Responses, CMC Variation Filling, Communication, Relationship Management, Meeting Deadlines, Multi-tasking

Industry

Pharmaceutical Manufacturing

Description

Main duties and responsibilities: Understanding of Regulatory strategy and documentation requirements Act as responsible Regulatory Team member for assigned regulatory projects Prepare regulatory documentation for DCP, MRP and National applications in line with assigned timelines Liaise with external Regulatory authorities as required. Ensure policies and procedures are properly understood, evaluated and carried out. Make sure modifications are investigated if necessary. Liaise with various departments to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products Compile and monitor the progress of scientific responses to deficiencies raised by the Regulatory authorities Preparation of submissions including CMC variation filling. Experience, skills and qualifications required: BSc Degree in Chemistry, Biology or relevant field. 1-2 years of experience in Regulatory Affairs / CMC within a Pharmaceutical organization. Fluent in English and good MS Office skills Strong organization skills, multi-tasking and able to meet deadlines Effective communication and relationship management Knowledge of CMC and global regulatory guidelines Ability to work under pressure, resilience The Company offers competitive remuneration, continuous learning and development opportunities, and a friendly and challenging working environment.

Responsibilities

The role involves understanding regulatory strategy and preparing documentation for DCP, MRP, and National applications while liaising with external regulatory authorities. Responsibilities also include ensuring policy adherence, investigating modifications, and supporting internal regulatory compliance activities for registered products.